Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06313437 · ClinicalTrials.gov registry record · Phase 1
Revumenib in Combination With 7+3 + Midostaurin in AML
A Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by Richard Stone, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT06313437: Recruiting Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by Richard Stone, MD.
NCT06313437 is a Phase 1 study of Acute Myeloid Leukemia and Leukemia that is actively recruiting participants, run by Richard Stone, MD. The registered enrollment target is 22 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06313437, a Phase 1 study of Acute Myeloid Leukemia and Leukemia, is actively recruiting participants, sponsored by Richard Stone, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML). The names of the study drugs involved in this study are: * Revumenib (SNDX-5613) (a type of menin inhibitor) * Midostaurin (a type of multi-kinase including FLT3 inhibitor) * Cytarabine (a type of antineoplastic agent) * Daunorubicin (a type of antineoplastic agent)
Primary Outcome
Detailed DLT consideration outline in protocol section 5.4.
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Revumenib
- DRUG Midostaurin
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-12-06 |
| Est. Completion | 2027-03-02 |
| Phase | Phase 1 |
What NCT06313437 shows while recruiting
NCT06313437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (81% lower).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cytarabine is the first listed.
NCT06313437 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06313437 about?
NCT06313437 is a clinical study titled "Revumenib in Combination With 7+3 + Midostaurin in AML". This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostauri...
What is the current status of trial NCT06313437?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2024-12-06. Estimated completion is 2027-03-02.
What conditions does trial NCT06313437 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia, AML, AML, Adult, AML With Gene Mutations.
What interventions are being tested in trial NCT06313437?
The interventions under investigation include: Cytarabine (DRUG), Daunorubicin (DRUG), Revumenib (DRUG), Midostaurin (DRUG).
Who is sponsoring clinical trial NCT06313437?
This trial is sponsored by Richard Stone, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06313437 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06313437's enrollment target sits among peer trials
22 236th of 306 higher than 64 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
RECRUITING · Phase 1
-
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
RECRUITING · Phase 1
-
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML
RECRUITING · Phase 1
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
- NCT04640987 · 22 participants · Phase 1
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI